JP2022077035A - Respiratory mask with nasogastric tube path - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a respiration mask capable of providing therapy to patients who also require a nasogastric tube (NG).

SOLUTION: A mask seal can include a path that is designed to deform around an NG tube 54 or other without lifting a mask 52 away from a face 70 of a patient 50. The deforming path can help to minimize gaps that form between the patient's face and the cushion as a result of the tube, thus reducing leaks and improving the efficacy of the treatment.

SELECTED DRAWING: Figure 1

COPYRIGHT: (C)2022,JPO&INPIT

Description

Incorporation by reference to any priority application Any application for which a foreign or domestic priority claim is made is incorporated herein by reference and is part of this disclosure.

The present disclosure relates generally to respiratory masks such as those intended for use in non-invasive ventilation (NIV). More specifically, the present disclosure is a seal or cushion for an NIV mask or other mask, eg, a nasal gastric (NG) tube, a nasal jejunal (NJ) tube and / or an oral gastric (OG) tube. With respect to seals or cushions that improve the sealing function of the mask when used in combination with tubes such as.

NIV masks are commonly used for patients who also require NG, NJ and / or OG tubes for drug delivery or delivery. Traditionally, NIV masks have not been designed to be used in combination with NG, NJ and / or OG tubes, and therefore, if such a combination is desired, the efficacy of NIV treatment may be compromised.

Conventional NIV masks have a silicone or thermoplastic elastomer (TPE) seal / cushion that is shaped to fit the patient's face to provide an airtight seal. These cushions are generally flexible, but not enough to fit facial features where the cushions are very small. In situations where it is desired that an NG, NJ and / or OG tube be used in combination with an NIV mask, the mask is usually placed on top of the tube. The tube lifts the cushion away from the patient's face, creating a gap around the tube, which breaks the seal and causes leakage.

Several techniques are currently used to minimize gaps and reduce leaks. These techniques include tightening the mask tighter to the patient, using sticky pads to fill the gap between the tube and cushion and the patient's face, or masking the NG, NJ and / or OG tube. It is possible to pass through the port of. Tightening the mask can be uncomfortable for the patient and can lead to pressure-related skin damage. The tight fit of the mask can deform the NG, NJ and / or OG tubes, which can also result in blockages within the tubes. The use of sticky pads brings extra work to clinicians who are fitting NG tubes or other tubes and masks, which is another component that sticky pads must fit and align. Because it is. In addition, if the tube is too large or too small, or if the tube and / or pad is not properly aligned, the pad may not be able to effectively close the gap. By passing the NG, NJ and / or OG tube through the port of the mask, any breaks caused by the tube in the seal are eliminated, but in many cases it is necessary to remove the tube in order to remove the mask. Removing and replacing the NG, NJ and / or OG tube can be uncomfortable and irritating to the patient.

The systems, methods and devices described herein have innovative embodiments, none of which are essential, nor are they solely responsible for their desired attributes. Without limiting the scope of the claims, some of the advantageous features are summarized here.

Some features, embodiments and advantages of the embodiment include a breathing mask with a cushion designed to adapt to an NG, NJ and / or OG tube that passes between the mask and the patient's face. The cushion has a predetermined thin area that is designed to fit the shape of the NG, NJ and / or OG tube, which area may be inherently provided between the cushion and the patient's face. , Can help reduce or minimize leak-causing gaps.

In some configurations, the cushion for the breathing mask comprises a facial contact area and at least one thin area within the facial contact area. The thin area is adapted to accommodate the placement of the tube between the facial contact area and the user's face.

In some configurations, at the time of use, at least one thin area is adapted to fit the shape of the tube while substantially maintaining the user's face and proper seal.

In some configurations, at least one thin area is located on the side of the facial contact area.

In some configurations, at least one thin area comprises a thin area on each side of the facial contact area.

In some configurations, the thin area on one side is a relatively large thin area and the thin area on the other side is a relatively small area.

In some configurations, the at least one thin area comprises two or more thin areas on one side of the facial contact area. In some configurations, the first and second thin-walled regions of the two or more thin-walled regions are spaced apart from each other. In some configurations, the first thin-walled region and the second thin-walled region are spaced apart along the outer periphery of the facial contact portion. In some configurations, the two or more thin-walled regions include at least one relatively large thin-walled region and at least one relatively small thin-walled region.

In some configurations, at least one thin area extends in the direction from the inner edge of the facial contact portion to the outer edge of the facial contact portion.

In some configurations, at least one thin area extends downward with respect to the horizontal axis from the inner end to the outer end. In some configurations, at least one thin area extends downward at an angle of about 5 degrees to about 45 degrees.

In some configurations, the cushion comprises a smooth transition of thickness between at least one thin area and an adjacent portion of the facial contact area. In some configurations, the transitions are substantially linear.

In some configurations, the thickness of at least one thin area is about 5 percent to about 80 percent the thickness of the adjacent portion of the facial contact area. In some configurations, the thickness of at least one thin area is about 10 percent to about 30 percent the thickness of the adjacent portion of the facial contact area.

In some configurations, the edges of at least one thin area are curved.

In some configurations, the inner edges of at least one thin area are spaced outward from the inner edge of the facial contact area.

In some configurations, the outer edges of at least one thin area are spaced inward from the outer edge of the facial contact area.

In some configurations, the tube is a feeding tube.

In some configurations, the cushion further comprises a visual alignment indicator that indicates the proper position of the tube.

In some configurations, the patient interface comprises a cushion comprising a facial contact area and at least one thin area within the facial contact area, at least in part. The thin area is adapted to accommodate the placement of the tube between the facial contact area and the user's face.

In some configurations, the cushion is adapted to create a seal around the user's nose and / or mouth.

In some configurations, the cushion is configured so that the upper part of the cushion can be deflected forward relative to the lower part of the cushion.

In some configurations, headgear holds the patient interface on the user's head. In some configurations, the frame portion interfaces with the headgear and the cushion interfaces with the frame portion.

In some configurations, the cushion comprises a relatively soft portion that defines the facial contact area and a relatively rigid portion that faces away from the relatively soft portion.

In some configurations, at least one thin area is located on the side of the facial contact area.

In some configurations, at least one thin area comprises a thin area on each side of the facial contact area.

In some configurations, the at least one thin area comprises two or more thin areas on one side of the facial contact area.

In some configurations, at least one thin area extends downward with respect to the horizontal axis from the inner end to the outer end.

In some configurations, the cushion comprises a smooth transition of thickness between at least one thin area and an adjacent portion of the facial contact area.

In some configurations, the thickness of at least one thin area is about 5 percent to about 80 percent the thickness of the adjacent portion of the facial contact area. In some configurations, the thickness of at least one thin area is about 10 percent to about 30 percent the thickness of the adjacent portion of the facial contact area.

In some configurations, the patient interface includes a visual alignment indicator that indicates the proper position of the tube.

Reference numbers may be reused throughout the drawing to indicate the overall correspondence between reference elements. The drawings are provided to illustrate the embodiments described herein and are not intended to limit the scope of this disclosure.

Figure shows a patient wearing a breathing mask (eg, NIV mask), which is combined with a tube (eg, NG tube) that extends downward and out of the lower left side of the mask as seen by the patient. And are arranged and configured according to some of the features, aspects and advantages of the present disclosure. FIG. 3 is a contour view of the mask seal or cushion of FIG. 1 that fits or shapes the NG tube as compared to the standard mask shown by the dashed line. It is a contour view of the cushion of the mask of FIG. 1 in which the NG tube does not exist. FIG. 3 is a perspective view of a portion of the mask of FIG. 1, showing a curvilinear contour of a thin-walled region of the cushion. FIG. 3 is a rear view of a portion of the mask of FIG. 1, showing the angled orientation of the thin-walled area of the cushion. FIG. 3 is a rear view of a portion of the mask of FIG. 1 in which a cross section is drawn through a portion of the cushion including a thin area. FIG. 6 is an enlarged view of a cross-sectional portion of the cushion including the thin-walled region of FIG. It is sectional drawing of the part of the cushion including the thin-walled region along line 8-8 of FIG. It is a contour of the shape of a thin-walled region in a flat state. It is a rear view of the mask which shows the pair of thin-walled regions of each side of a cushion, the thin-walled regions of the same side are different in size, and the thin-walled regions are symmetrical between the sides. FIG. 3 is a perspective view of two different mask portions having different types of visual alignment indicators to facilitate positioning of the tube with respect to the cushion.

Undesirably high leakage rates generally occur in situations where NG, NJ and / or OG tubes are used in combination with NIV masks. High leak rates can compromise the quality of treatment a patient receives, and the methods currently used to improve leaks can lead to unwanted side effects. Some features, embodiments and advantages of the disclosed embodiments are intended to provide useful alternatives to currently known approaches to address and mitigate these leaks.

The following description of some features, embodiments and benefits of some embodiments refers to breathing masks designed and configured for use in combination with NG tubes, or made to be used. It should be understood that the mask can also be used in combination with NJ tubes, both NG and NJ tubes (more commonly), or any combination of NJ tubes, NG tubes or OG tubes. Breathing masks can also be used or made to be used with other types of tubes that are desired to pass between the mask cushion or seal and the patient's skin. Therefore, when referring to an NG tube herein, it also includes any combination of NJ tubing, OG tubing, other tubing (eg, fluid drain tubing) or NG tubing, NJ tubing, OG tubing and other tubing. Can be pointed to.

Although the illustrated breathing mask is a NIV mask, the features, embodiments and advantages described herein can be applied similarly to other types of masks. Some features, aspects and benefits of the mask are described with respect to providing treatment to adults, but some features, embodiments and benefits of the present disclosure include, but are not limited to, neonatal, infant and pediatric patients. It can also be applied to breathing masks for all age groups.

FIG. 1 shows a user or patient 50 wearing a breathing (eg, NIV) mask 52 in combination with an NG tube 54. The illustrated mask 52 includes a mask body or interface 56, which includes a cushion or seal 58 that contacts the user's face and surrounds the user's nose and / or mouth. The interface 56 also includes, or is connected to, a conduit connector 60 that allows the interface 56 to be connected to one or more gas conduits (not shown). In the illustrated configuration, the conduit connector 60 is in the form of an elbow. A headgear 62 is coupled to the interface 56 to hold the interface 56 in place on the patient's face.

The interface 56, conduit connector 60 and headgear 62 can take many different forms. For example, the interface 56 can be a nasal interface that covers only the user's nose, or a full-face interface that covers both the nose and mouth. Although the full face interface 56 is illustrated, the present disclosure can be applied to other interface types where a tube is desired to be passed between the interface cushion or seal and the user's face. The interface 56 can include or omit a forehead pad. In addition, the interface 56 (in some configurations, the conduit connector 60) can be an integral structure or an assembly of several components as shown. The illustrated interface 56 includes a cushion module 64, which in some configurations includes a relatively rigid housing 66 and a relatively soft seal 58. The interface 56 also includes a frame 68, which can support the cushion module 64 and can provide a connection or mooring position for the headgear 62. Headgear 62 may be of any suitable configuration, including single-loop or multi-loop configurations.

Typically, the NG tube 54 extends from the nose to the cheeks and exits from the side of the mask 52. In a conventional mask, as shown by the dashed line in FIG. 2, this configuration may result in the formation of a gap between the mask seal and the corresponding surface of the user's face 70. The conventional cushion is flexible but shaped into the tube 54 to the extent necessary to prevent gas leaks at an undesiredly high rate through the gap between the cushion and the user's face 70. Cannot fit into. Instead, the relatively large length of the cushion can be lifted from the user's face 70 and curved over the tube 54, leaving a gap on either side of the tube 54, where a leak can occur. be. Generally, the larger the diameter of the NG tube 54, the larger the size of the gap.

Some features, aspects and advantages of this embodiment are that the shape can be adapted to the NG tube 54 to a degree sufficient to generate or maintain a suitable seal with the user's face 70, shape matching or By providing the mask cushion 58 with a high compliance area 72, it is intended to reduce the gap formed between the mask cushion 58 and the surface of the user's face 70 when the NG tube 54 is used. be. The shape-fitting or high-compliance region 72 may be any suitable configuration that increases the shape-fitting or compliance of a portion of the cushion 58 with respect to adjacent or surrounding parts of the cushion 58. As described herein, the shape conformance or high compliance region 72 can be, or include, a region of thinning material or a region of different material, among other possible configurations.

Preferably, the shape conformance or high compliance area 72 allows the cushion 58 to generate or maintain a better seal with the user's face 70 than conventional mask cushions. In some configurations, the cushion 58 has less gas leakage between the cushion 58 and the user's face 70 as compared to a conventional cushion and can accommodate the NG tube 54. In some configurations, the cushion 58 has no or substantially no gas leak between the cushion 58 and the user's face 70, or a rate that is considered to be detrimental to the prescribed treatment. With a gas leak below, the NG tube 54 can be accommodated. In some configurations, the leakage rate by the cushion 58 accommodating the NG tube 54 within the shape conforming or high compliance area 72 is less than about 25 L / min at the nominal pressure or flow range for the prescribed (eg, NIV) treatment. Is. In some configurations, the leakage rate is less than about 20 L / min, less than about 15 L / min, or less than about 10 L / min.

FIG. 2 shows a contour view of the NG tube 54 passing between the cushion 58 and the user's face 70. The shape-matching or high-compliance area 72 provides a more compliant and flexible tube passage than the perimeter or adjacent portion of the cushion 58. In some configurations, the shape conformance or high compliance area 72 is more compliant and flexible than any other part of the cushion 58. FIG. 2 shows how the shape-matching or high-compliance region 72 stretches and deforms around the tube 54, whereby the gaps at the sides of the tube 54 are much smaller than a cushion without a specially constructed tube passage. Indicates. The size of the gap depends largely on the tube size used. In FIG. 2, it is clear that the mask cushion 58 does not lift from the face 70 in order to accommodate the NG tube 54 to the same extent as the conventional mask cushion that does not include the tube passage.

The NG tube 54 has a cross-sectional dimension or diameter 74 that extends away from the user's face 70. Preferably, the shape-matching or high-compliance region 72 allows the cushion 58 to touch or shape at least a substantial portion of the NG tube 54 that does not touch the user's face 70. In some configurations, the shape-matching or high-compliance region 72 allows the cushion 58 to remain in contact with or shape at least the outer 1/3 76 of the face of the NG tube 54 opposite the user's face 70. Can be adapted. In some configurations, the shape-matching or high-compliance region 72 allows the cushion 58 to remain in contact with or shape-fit at least the outer 1/2 78 of the surface of the NG tube 54. In some configurations, the shape-matching or high-compliance region 72 allows the cushion 58 to remain in contact with or shape-fit at least the outer 2/380 of the surface of the NG tube 54. In some configurations, the shape-matching or high-compliance region 72 allows the cushion 58 to remain in contact with or shape-fit with substantially the entire surface of the NG tube 54 that is not in contact with the user's face 70. Can be done.

FIG. 3 shows a contour view of the mask cushion 58 of FIG. 2 used without the NG tube 54. FIG. 3 shows that in the absence of the NG tube 54, the shape-matching or high-compliance region 72 significantly leans against and contacts the user's skin 70. The outer surface of the shape-fitting or high-compliance region 72 can be shaped such that the shape-fitting or high-compliance region 72 or the pipe passage substantially follows the same contour as the rest of the mask cushion 58. Such a configuration helps the shape-matching or high-compliance region 72 to seal with the patient's face 70, which preferably results in very few leak passages formed in the absence of the NG tube 54. It is beneficial for the shape conformance or high compliance area 72 to substantially follow the shape of the rest of the cushion 58, which is such that the mask 52 is used by a wider range of users than is inherently possible. This is because it is more versatile and suitable. For example, the illustrated mask 52 can be used for any user or patient in need of NIV treatment, regardless of the need for use with the tube. Preferably, the surface facing or contacting the patient in the shape-matching or high compliance area 72, or the contact surface of the adjacent or surrounding portion of the cushion 58, defines a continuous or uninterrupted surface. That is, preferably there are no breaks or other interruptions in the surface facing or contacting the patient within or adjacent to the shape conformance or high compliance area 72.

In some configurations, there may be a slight step on the outer surface of the cushion 58. The few steps may be intentional or the result of the material, configuration or manufacturing process used to produce the shape conformance or high compliance area 72. The steps can be small enough to minimize leaks. The shape-matching or high-compliance region 72 may be flexible enough to expand under the pneumatic pressure applied by the treatment so that the inflated portion fills any gaps that the surface steps may inherently provide. ..

As mentioned above, the shape conformance or high compliance region 72 can be any suitable configuration that provides compatibility for the type or size of the tube intended for use with the tube 54 or mask 56. In some configurations, the shape fit or high compliance area 72 is substantially more shape fit or compliant than the perimeter or adjacent portion of the cushion 58. In some configurations, the increased shape fit or compliance is at least partially the result of using different materials in the shape fit or high compliance area 72 relative to or adjacent to the cushion 58. For example, increased shape conformance or compliance can be achieved by the topical use of more elastic and flexible materials. Different materials can have a higher elastic modulus or a different modulus of elasticity compared to the material in the area around or adjacent to the cushion 58. The material can include, for example, without limitation, different grades of silicone, which is a harder or more flexible TPE. In some configurations, the different material can also have a different thickness (eg, a smaller thickness) compared to the material in the area around or adjacent to the cushion 58. Any suitable process, or any other suitable method, which can include, for example, without limitation, an adhesive or chemical bond or co-molding or overmolding process in the material around or adjacent to the cushion 58. Allows different materials to be combined. In configurations where different materials are utilized for the shape-fitting or high-compliance region 72, the different materials can extend beyond the shape-fitting or high-compliance region 72. For example, such a configuration can provide a larger surface area partial overlap for joining the two materials together.

In some configurations, the shape conformance or high compliance area 72 is or includes a area of thinning material. In the illustrated configuration of FIGS. 4-8, the shape conformance or high compliance region 72 includes a region of thinning material that is the same material as the material of the region around or adjacent to the cushion 58. Therefore, the area of the thinning material can be formed integrally with the area around or adjacent to the cushion 58. Hereinafter, the shape conforming or high compliance region 72 will be referred to as a thin-walled region or a thin-walled region. However, given the alternative structure to the shape-fitting or high-compliance region 72, when thus referred to as a thin-walled region, it can also generally include other types of shape-fitting or high-compliance regions as well. The shape-matching or high-compliance area 72 can define one or more tube passages that adapt to the passage of the NG tube 54 or other tube between the cushion 58 and the user's face 70, and thus the book. It can also be referred to as a tube passage in the specification. In some configurations, the one or more tube passages 72 are formed to be thinner than the adjacent portions of the cushion 58. In some configurations, the one or more tube passages 72 are formed to be thinner than any other portion of the cushion 58.

4-8 show a cushion module 64 that is separate from the rest of the mask 52. As mentioned above, the cushion module 64 comprises a housing 66 and a seal or cushion 58. In the illustrated configuration, the shape conformance or high compliance area 72 of the seal 58 is or includes a thin wall area. Preferably, the thin area 72 is defined by a sealing wall, which can be shaped by the tube 54 with respect to adjacent or other portions around the cushion 58. The cushion 58 generally has a patient facial contact portion or surface 90 and an anterior portion or surface 92 of the facial contact portion 90. The face contact portion 90 generally faces rearward and comes into contact with the user's face 70. The facial contact portion 90 can be deformed when placed in contact with the user's face 70, and the entire posterior facing portion is with or without all the user's face or all situations or treatments. May not touch under. In the illustrated configuration, the upper portion of the cushion 58 is deflected forward with respect to the lower portion of the cushion 58 to better accommodate possible variations in user nose shape. Examples of such configurations are disclosed in Applicant's PCT Application International Publication No. 2014/0627070, the entire contents of which are incorporated herein by reference and are part of this disclosure. The cushion 58 can be made from one or more generally flexible materials such as, for example, without limitation, silicone or TPE.

In FIGS. 4 and 5, the position of the thin-walled region 72 is shown on the outer surface of the cushion 58 by a contour view. However, preferably, the thin area 72 is defined by a recess 94 defined by the inner surface of the cushion 58, as shown in FIGS. 6-8. The shape of the thin area 72 may be configured or made to match the size or shape of the tube intended for use with the mask 52. In some configurations, the thin area 72 can be placed at least partially or completely within the facial contact portion 90 of the cushion 58. Referring to FIG. 5, the thin region 72 generally extends in the direction from the inner edge 96 of the face contact portion 90 toward the outer edge 98 of the face contact portion 90. In some configurations, the thin area 72 can be spaced apart from one or both of the inner edge 96 and the outer edge 98. In some configurations, as shown in FIG. 4, the thin area 72 can extend beyond the outer edge 98 of the facial contact portion 90 and into the anterior portion 92 of the cushion 58.

In some configurations, the thin area 72 is angled with respect to the horizontal axis 100 of the cushion 58 or cushion module 64. The vertical axis 102 can vertically divide the cushion 58 or the cushion module 64, the horizontal axis 100 is perpendicular to the vertical axis 102 and extends laterally to the cushion 58 or the cushion module 64. There is. The axis 104 and the horizontal axis 100 of the thin area 72 can define an angle between them of about 5 degrees to about 45 degrees, or, if desired, a larger angle. In one configuration, the angle between the axis 104 and the horizontal axis 100 is about 20 degrees. In the illustrated configuration, the inner edge 106 of the thin area 72 closer to the centerline or vertical axis 102 is higher than the outer edge 108 of the thin area 72 farther from the centerline or vertical axis 102. Such a configuration corresponds to a typical passage of the NG tube 54 as shown in FIG. However, the thin area 72 can be provided in other orientations as needed to suit other uses. For example, an oral gastric (OG) tube can extend through the cushion 58 at about 0 degrees or generally along the horizontal axis 100. Therefore, a predetermined orientation of the thin-walled region 72 can be selected as needed, taking into account a particular tube, tube orientation or other related factors.

The thin area 72 can have any suitable size or shape such that it is configured or made to fit the size or shape of the tube intended to be used with the mask 52. In the illustrated configuration, the thin area 72 defines substantially linear side edges 110 and 112 extending between the inner and outer ends 108. The side edges 110 and 112 can be substantially parallel to each other. The axis 104 can be defined as a line parallel to and equidistant from the side edges 110, 112. In some configurations, one or both of the inner end 106 and the outer end 108 can have a curvilinear or substantially semi-circular contour, as shown in FIGS. 4 and 5. Due to this shape, the relatively thick side wall structure of the cushion 58 protrudes to the circumference of the NG tube 54, and the thin-walled region 72 is deformed between the relatively thick side wall and the tube 54. The thin area 72 is thin enough to deform and stretch over the NG tube 54 where the mask 52 is intended or allowed to be used without significantly lifting the cushion 58 away from the patient's face 70. can do. In some configurations, lift does not occur or virtually does not occur. The curvilinear shape of the ends 106, 108 of the shape-fitting region 72 minimizes the possibility that the NG tube 54 will be deformed or squeezed by a relatively thick portion adjacent to the wall portion of the cushion 58. be able to.

6 to 8 show cross-sectional views of the thin-walled shape conforming region 72 of the cushion 58. In the illustrated configuration, the inner surface of the cushion 58 may shrink or gradually shrink from a relatively thick wall portion to a relatively thinner and more shape-fitting portion 72, while the outer surface may remain substantially unchanged. It can be lowered to define the inner recess 94. In other words, the outer surface is continuous and uninterrupted between the thin area 72 and the adjacent or surrounding portion of the cushion 58. However, in some configurations, the outer surface may include a recess in addition to or instead of the inner recess 94, and the internal gas pressure to form a seal with the user's face 70 in the absence of the tube 54. Can depend on the resulting swelling of.

The recess 94 can define a length 114 along the axis 104 and a height 116 in a direction perpendicular to the axis 104. The length 114 can be selected to extend along the length of the facial contact portion 90 that may come into contact with the user's face 70 under typical or expected operating conditions. In some configurations, the length 114 is from about 15 mm to about 20 mm. The length 114 can vary depending on the size of the cushion 58, or can remain constant between cushions 58 of different sizes. For example, the length 114 can vary from about 15.5 mm for the small cushion 58 to about 19 mm or 19.3 mm for the large cushion 58. The height 116 can be selected to accommodate the diameter or cross-sectional dimensions of the tube in which the mask 52 is designed or intended to be used. In some configurations, the height 116 is substantially equal so that the mask 52 is somewhat larger than the diameter of the maximum tube size designed or intended to be used. In some configurations, the height 116 is about 5 mm to about 15 mm, or about 10 mm to 12 mm. The height 116 can vary depending on the size of the cushion 58, such as about 9 mm for ultra-small cushions, about 10 mm for small and intermediate cushions, and about 11 mm for large cushions. Alternatively, the height 116 can remain constant between cushion sizes.

The thin area 72 defines a wall thickness 118 smaller than the wall thickness 120 of the portion of the cushion 58 adjacent to or surrounding the thin area 72. Preferably, the wall thickness 118 of the thin area 72 is smaller than the wall thickness 120. In some configurations, the wall thickness 118 is about 5 percent to about 80 percent, or about 10 percent to about 30 percent of the wall thickness 120. In some configurations, wall thickness 118 represents a reduction in thickness relative to wall thickness 120 of about 70 percent to about 95 percent, or about 80 percent to about 90 percent. For example, in some configurations, the wall thickness 120 can be about 1.49 mm or 1.5 mm, and the wall thickness 118 can be about 0.1 mm to about 0.5 mm, or about 0.15 mm to about 0. It can be 0.3 mm. In some configurations, the wall thickness 118 is about 0.3 mm. The wall thickness 118 in the recess 94 is shown as substantially constant (not including the transition portion between the recess 94 and the peripheral or adjacent portion of the cushion 58). However, in other configurations, the wall thickness 118 can vary within the recess 94.

The cushion 58 can define a depth 121 (FIG. 8) in the anteroposterior direction from the rearmost point of the patient contact portion 90 at the height of the thin area 72 and the position of the outer end 108 of the thin area 72. Having a sufficient height 121 can help the cushion 58 keep the NG tube 54 in place and in contact with the user's face 70. However, preferably, the depth 121 is not too large, i.e., the thin area 72 extends extremely towards or into the anterior portion 92 of the cushion 58 to avoid unnecessary weakening of the cushion 58. do not. Depth 121 can be associated with the size of the tube 54 designed and intended for use by the mask 52. In some configurations, the depth 121 is from about 10 mm to about 20 mm, or from about 15 mm to about 18 mm. The depth 121 depends on the size of the cushion 58, such as about 14 mm or 14.3 mm for an ultra-small cushion, about 15.7 mm or about 16 mm for a medium-sized cushion, or about 17.8 mm or 18 mm for a large cushion. Can change. Alternatively, the depth 121 can remain constant between cushion sizes.

In some configurations, the thickness transition between the recess 94 and the adjacent or peripheral portion of the cushion 58 can be relatively steep. The steep transitions allow the creation of bend points that limit the deformation that may be caused by the tube to the relatively thin region 72 of the cushion 58. The relatively thin area 72 can be deformed, stretched and / or agglomerated until it encounters a relatively thick wall portion, thereby limiting further deformation. In other configurations, the thickness transitions may not be so steep, as indicated by the dashed lines at the edges of the recesses 94 in FIG. Smooth or less steep transitions may be preferred for other reasons, for example for manufacturability reasons. Preferably, the transition is limited to a relatively small distance from the recess 94 or a relatively small area surrounding the recess 94. For example, the transition may be substantially linear and / or at an angle sufficient to allow practical removal of the molded cushion 58 having the thin area 72 from the mold. obtain. In some configurations, the transition region preferably extends less than or equal to the width or length of the thin-walled region 72, away from the thin-walled region 72, and preferably less than or equal to the width or part of the width or length of the thin-walled region 72 (preferably less than or equal to the width or length of the thin-walled region 72. For example, less than 1/2, 1/3 or 1/4 of the width or length of the thin area 72), extending.

FIG. 9 shows an example of the contour of the recess or the thin-walled region 72 in the flattened state. In practice, the thin-walled region 72 may be curved or three-dimensional in shape because many patient contact surfaces of the mask cushion are curved laterally and / or vertically. In FIG. 9, each end portion 106, 108 of the thin-walled region 72 has a semi-circular shape centered on the respective center 122. Therefore, the sum of the distance 124 between the centers 122 and the radii of the ends 106 and 108 is equal to the entire length 114 of the thin area 72. In the illustrated thin-walled region 72, the side edges 110, 112 are parallel to each other, and the ends 106, 108 have equal radii. However, in other configurations, the thin area 72 can have other suitable shapes.

In some configurations, such as those shown in FIG. 10, shape-matching thin-walled regions or tube passages 72 can be provided at multiple locations. FIG. 10 shows a rear view of the cushion 58 in which the two tube passages 72 are spaced apart from each other along the outer periphery of the cushion 58 and are symmetrically arranged on each side of the mask 52. The presence of passages 72 on each side of the mask 52 allows the NG tube 54 to be secured to either side of the patient's face 70. Alternating use of NG tubes 54 between the patient's nostrils is common practice to reduce irritation and tissue damage within the nasal passages. The symmetrical tube passage 72 in the mask 52 allows the clinician to change the side to which the NG tube 54 is fixed and continue to use the same mask 52. With such a configuration, wasteful loss of instruments can be reduced and work for the clinician can be reduced. Further, the tube passages 72 on both sides allow the cushion 58 to be sealed when both the NG tube 54 and the NJ tube are used simultaneously.

FIG. 10 also shows two different tube passages 72 sizes. Since the NG tube 54 comes in a variety of sizes, it is beneficial that the tube passage 72 can be adapted to any size or at least a commonly used size. It may be desirable for the mask 52 to have more than one aisle size to cover a wider range of tube diameters, at least with acceptable leakage rate performance. If the tube is too small for the tube passage 72, the relatively thick wall portion of the cushion 58 may not be able to adequately limit the deformation of the thin area 72 and gaps may be formed. , This gap can lead to leaks. The size of the tube passage 72 can be defined to fit a range of tube diameters. As mentioned above, it is desirable that the round / circular contour of the tube passage 72 generally correlates or matches the tube diameter. By closely matching or generally correlating the tube passage 72 with the tube 54, the relatively thick wall portion allows the thin area 72 to be forced to fit around the tube 54.

It is preferable that there are too many tube passages 72 or the tube passages 72 are not too large, as they can reduce the structural integrity of the cushion 58. The relatively thick wall portion of the cushion 58 can be designed to provide structure and support to the mask 52. The cushion 58 may be provided with a structure that reduces or eliminates the possibility of the cushion 58 collapsing when the mask 52 is fastened to the patient 50. When the cushion 58 is crushed, leakage can occur and the rigid plastic mask frame 68 can be pressed against the patient's face 70, causing discomfort. Therefore, the number and size of the tube passages 72 can be limited so that the structure of the cushion 58 is less likely to be compromised. The cushion 58 can include, for example, any one or any combination of the tube passages 72 shown in FIG. In some configurations, the cushion 58 may include a single tube passage 72 on one side or a single tube passage 72 on each side. In a configuration with at least one tube passage 72 on each side, the tube passages 72 can have the same size or different sizes. For example, the cushion 58 may include a relatively small tube passage 72 on one side and a relatively large tube passage 72 on the other side. In some configurations, the cushion 58 includes a small tube passage 72 and a large tube passage 72 on each side.

Typically, the NG tube 54 extends from below the patient's nose across the patient's lips and across the cheeks. The tube 54 is usually secured to the nose with tape. The one or more tube passages 72 are preferably approximately aligned with the underside of the patient's nose so that the tube 54 can be secured to the patient 50 in approximately conventional positions for ease of use by the clinician. It is placed on the cushion 58 so that it does or is somewhat lower. It may be beneficial to place the tube 54 over the soft portion of the patient's cheek, anywhere below the cheekbone, to minimize the occurrence of compression wounds. By arranging the tube passage 72 on the cushion 58 in this way, the clinician can continue to use the conventional technique of adapting and fixing the NG tube 54. In some configurations, the tube passage 72 is located in the lower half of the cushion 58 or in the lower third of the cushion 58. The tube passage 72 can be placed at the widest point of the full face cushion 58, near or slightly above it. In some configurations, the tube passages 72 are spaced above the lowest point of the inner edge of the cushion 58.

11A and 11B show embodiments of the cushion module 64 of the mask 52 having the visual alignment index 130. Indicator 130 is intended to provide the clinician with a visual clue to position the mask 52 on top of the NG tube 54 of the patient's face 70. In order for the illustrated mask 52 to work effectively, it is desirable that the NG tube 54 be accurately aligned with the tube passage 72 above the mask cushion 58. Improper alignment can increase leakage rates. The alignment index 130 may be in the form of an arrow or label pointing in the direction of the NG tube passage 72. The index 130 can be placed in close proximity to the tube passage 72 on the cushion 58 as shown in FIG. 11A, or on the mask body (eg, housing 66 or frame 68) as shown in FIG. 11B. Can be placed. Embossing, printing, laser etching, molding or other marking techniques can be used to form the index 130 on the mask 52.

Unless expressly stated otherwise in the context, the terms "prepared", "prepared", etc. are included throughout the specification and claims as opposed to their exclusive or exhaustive meaning. It should be interpreted in a specific sense, that is, "including, but not limited to,". In particular, conditional language used herein, such as "can," "possible," "possible," "may," and "for example," is used or unless otherwise specified. To suggest that, in general, some embodiments include some features, elements and / or states, but not others, unless understood in other senses within the context in which they are used. Intended. Therefore, such conditional language is generally not intended to suggest that a feature or element is always required for one or more embodiments.

The term "plurality" refers to having more than one item. The term "about" or "approximate" does not require the quantity, dimensions, size, formulation, parameters, shape and other features to be accurate, but tolerable tolerances, conversion factors, rounding, measurements as needed. It means that it may be approximated and / or larger or smaller, reflecting errors, etc., and other factors known to those of skill in the art. The term "substantially" does not require the listed features, parameters or values to be achieved exactly and includes, for example, tolerances, measurement errors, measurement accuracy limits and other factors known to those of skill in the art. Or it means that the variation can occur in an amount that does not rule out the effect that the property was intended to provide.

In the present specification, numerical data may be expressed or presented in a range format. These range formats are used solely for convenience and brevity and are therefore not only flexibly interpreted to include the numbers explicitly listed as the upper and lower limits of the range, but also included within that range. All of the individual numbers or subranges that are made should be interpreted to include each number and subrange as if they were explicitly listed. By way of example, the numerical range "about 1-5" is not interpreted to include only the explicitly listed values of about 1-5, but the individual values and subranges within the indicated range. Should also be interpreted to include. Therefore, in this numerical range, individual values such as 2, 3 and 4, and "about 1 to about 3", "about 2 to about 4" and "about 3 to about 5", "1 to 3", It includes lower ranges such as "2-4" and "3-5". This same principle applies to ranges that enumerate only one number (eg, "greater than 1") and should be applied regardless of the breadth of the range or the features described.

For convenience, multiple items may be presented in a common list. However, these lists should be interpreted as if each element of the list were individually identified as a separate and unique member. Therefore, any individual element of such a list is considered to be a de facto equivalent of any other element of the same list, solely on the basis that it is presented to a common group without the indication that it is the opposite. Should not be interpreted. In addition, the terms "and" and "or", when used with a list of items, use any one or more of the listed lines alone or in combination with other listed lines. It should be broadly interpreted in that it can. The term "alternatively" refers to the choice of one or more of two or more choices, either only the listed choices or one of the listed choices, unless otherwise specified in the context. It is not intended to limit the selection to just.

No reference to any prior art herein is an admission or any form of such indication that the prior art forms part of common general knowledge in the field of effort focus in any country of the world, and It should not be interpreted as such.

Wherever the above description refers to perfections or components with known equivalents, those perfections are incorporated herein as if they were individually shown.

The present invention is broadly defined as any combination of parts, elements and features individually or collectively referred to or indicated in the specification of the present application and any combination of two or more of said parts, elements or features. It is also possible to say that it is in.

It should be noted that various modifications and modifications to the currently preferred embodiments described herein will be apparent to those of skill in the art. Such modifications and modifications can be made without departing from the spirit and scope of the invention and without reducing its associated advantages. For example, various components can be repositioned as needed. Therefore, these variants and modifications are intended to be included within the scope of the invention. Moreover, not all features, embodiments and advantages are necessarily required to carry out the present invention. Therefore, the scope of the present invention is intended to be defined only by the following claims.

Claims (27)

A cushion for breathing masks
With the face contact part,
A cushion comprising at least one thin-walled region that is at least partially within the facial contact portion, the thin-walled region adapted to the arrangement of the tube between the facial contact portion and the user's face. The cushion according to claim 1, wherein at the time of use, the at least one thin area is adapted to fit the shape of the tube while substantially maintaining the user's face and a suitable seal. The cushion according to claim 1 or 2, wherein the at least one thin-walled region is arranged on the side portion of the facial contact portion. The cushion according to any one of claims 1 to 3, wherein the at least one thin-walled region includes a thin-walled region on each side of the facial contact portion. The cushion according to claim 4, wherein the thin-walled region on one side is a relatively large thin-walled region, and the thin-walled region on the other side is a relatively small thin-walled region. The cushion according to any one of claims 1 to 5, wherein the at least one thin-walled region includes two or more thin-walled regions on one side of the facial contact portion. The cushion according to claim 6, wherein the first thin-walled region and the second thin-walled region of the two or more thin-walled regions are arranged at intervals from each other. The cushion according to claim 7, wherein the first thin-walled region and the second thin-walled region are arranged at intervals along the outer peripheral portion of the facial contact portion. The cushion according to any one of claims 6 to 8, wherein the two or more thin-walled regions include at least one relatively large thin-walled region and at least one relatively small thin-walled region. The cushion according to any one of claims 1 to 9, wherein the at least one thin-walled region extends from the inner edge of the facial contact portion toward the outer edge of the facial contact portion. The cushion according to any one of claims 1 to 10, wherein the at least one thin-walled region extends downward with respect to a horizontal axis from an inner end portion to an outer end portion. 11. The cushion of claim 11, wherein the at least one thin area extends downward at an angle of about 5 degrees to about 45 degrees. The cushion according to any one of claims 1 to 12, further comprising a smooth transition portion in thickness between the at least one thin-walled region and an adjacent portion of the facial contact portion. 13. The cushion according to claim 13, wherein the transition portion is substantially linear. The cushion according to any one of claims 1 to 14, wherein the thickness of the at least one thin-walled region is about 5% to about 80% of the thickness of the adjacent portion of the facial contact portion. 15. The cushion of claim 15, wherein the thickness of the at least one thin area is from about 10 percent to about 30 percent of the thickness of the adjacent portion of the facial contact portion. The cushion according to any one of claims 1 to 16, wherein the end of the at least one thin-walled region is curved. The cushion according to any one of claims 1 to 17, wherein the inner end portion of the at least one thin-walled region is arranged at a distance from the inner edge of the facial contact portion to the outside. The cushion according to any one of claims 1 to 18, wherein the outer end portion of the at least one thin-walled region is arranged inwardly with an interval from the outer edge of the facial contact portion. The cushion according to any one of claims 1 to 19, wherein the tube is a feeding tube. The cushion according to any one of claims 1 to 20, further comprising a visual alignment index indicating an appropriate position of the tube. A patient interface comprising the cushion according to any one of claims 1 to 21. 22. The patient interface of claim 22, wherein the cushion is adapted to generate a seal around the user's nose and / or mouth. 22 or 23. The patient interface of claim 22 or 23, wherein the cushion is configured such that the upper part of the cushion can be deflected forward with respect to the lower part of the cushion. The patient interface according to any one of claims 22 to 24, further comprising a headgear adapted to hold the patient interface on the user's head. 25. The patient interface of claim 25, further comprising a frame portion adapted to interface with the headgear, wherein the cushion is adapted to interface with the frame portion. Any of claims 22-26, wherein the cushion comprises a relatively soft portion defining the facial contact portion and a relatively rigid portion facing away from the relatively soft portion. The patient interface described in paragraph 1.

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